Hollow filling and/or transfusion needle



Dec. 27, 1955 L. J. NOVAK ET AL 2,728,342

HOLLOW FILLING AND/OR TRANSFUSION NEEDLE Filed April 10, 1952 FIG-laFIG-l I wi l" INVENTORS I I MW LEO J. NOVAK MARION 0. FORD ATTORNEYSFIG- 4 United States Patent HOLLOW FILLING AND/OR TRANSFUSIGN NEEDLE LeoJ. Novak and Marion D. Ford, Daytonpflhio, as-

{signoss nto .rTlle rfiCommonwealth Engineering :Company v--.ef Qhio,:Daytou, Ohio, a corporation oi Ohio Application April '10, 1952, SerialN0.28.1,'5il6 Claims. '(Cl. .-128-,-221) Elihis invention :relates tothe filling and emptying of containers useful in tthe .artof,transfusion -.ofxsterile ma- :terialssuchr-as bloodrplasrna, blood, and-blood volume ex- ;ipamiers. "More particularly, the invention relatesto -the shallow needles :useful in the process.

rzsterile. materials to betransported are normally stored isterilecontainers and are secured and permanently :sealedwith a highqualitythickrubber stopper to' prevent ingressof .air to the bottle. Towithdraw liquid from such a .c-ontainer a hollow needle having a verysharp point onone end thereof is passed through the-stopper, While theother exposed end of the hollow needle is secured to the apparatus towhich the material-is tobe transferred.

In the filling of this type of'bottle it"iscustomary'comrnercialpractice for one manufacturer to sterilize,evacuateand-seal the-bottle with a rubber cap and-forward it -tothe'producer of the liquid'rnaterial for the'filling of the bot't les.when suchbottles are to be filled the outer end o'f the tneedle'issecured to the source otliquid which'is "to be placed in the bottle andthe sharpened needle-cud is -then -passed through the rubber'stopper andthe-liquid forced into the evacuated container. After filling the needleis withdrawn and the "high quality rubberstopper closes over the smallopening caused by the entrance of 'the needle, again sealing the bottle.Where required-addi- "t-ional' sealing 'meansrnay be appliedto'theopening'in-the rubber.

A-prirne difficulty in the filling cf'these bottles'has ibeen that'rubber particles are dislodged from the body of 'the rubber stopper asthe needle passes 'therethrough and these particles find theirway intosuch a circumstance occurs, whichis not infrequent, it 'isnecessarytodiscard the contaminated material.

It has now been found that-if a needle is provided having a long cuttingedge and a relatively small bearing surface in-contaetwitlrthe body ofrubber asrthenieedle passes therethrough; that the-possibility ofrubberpatiticles entering the :sterilizedrnaterial"is substantiallyeliminated, and itis accordingly a primary object'oithis invent'ionitoprovide a hollow needle having these characteristics.

It has also been found that it is particularly desirable in the fillingof bottles that the hollow needle should preferably only enter therubber body to an extent sufiicient to insure that vacuum conditions aremaintained, and accordingly it is another object of this invention toprovide a new method for the filling of the bottles.

The needle of invention as noted should have a particularly long cuttingedge and the cutting edge should form with the shank of the needle avery small angle, not greater than 12 degrees, and preferably not lowerthan 4 degrees. An angle of about 7 to 8 degrees has been found mostsuitable for the general purposes of this invention.

The invention will be more fully understood by reference to thefollowing detailed description and the accompanying drawings wherein:

Figures 1 and la, respectively, are front elevational the sterileliquid. When 2,728,342 Batented Dec. 27, 1955 ..:2 andside-elevationalviews illustrating the-needle of invention;

Figure 2 is a sectional view illustrating 'the needleof invention whenit is passed through the stopper ofithe bottle referred to hereinbefore;

Figure 3 isa view ta'ken on line 3-3 of FigureZ; and

Figure 4 is a-sohernatic view illustrating the apparatus for the fillingof the bottles.

The needleof invention is illustrated in-Figures 1 and la wherein thehollow needle '21 is providedwith the usual stepped portions 22, 23 and24 and an upper'portion 25, while the. cylindrical shank portionzd-isicutawayas at 27 in Figure l-a to provide acutawayportioncomprising long'cutting edges 2'1", 2-9 tapering inwardlyand-downwardly from the hollow cyl-indrical shank'portion to -a commonpiercing point, and a 'full length portion lying betweenthe edges and inthe 'same plane ast'he wall of the cylindrical portion of which it is acontinuation. NumeraP-ZS indicates the piercing pointof the needle.

As may be clearly seenfrom-Figure 2, *when the needle having a shank 26ispassed through a rubber stopper, cutting of the rubberwill take placesubstantially over the complete length of 'the passage and very littlefrictional resistance willoccur. The cutting of 'therubber'by'the'e'dges 27, 29evidently permits the rubber internally of thestopper to separate cleanly and due toits-naturzil resilience --to flowarountbthe edges 27, '29 and partially into theho'llowchan-nel 320f theneedle 21. Thisla'tter arrangementis most clearly seen in 'Figure 3.

Since "the portion 30 of-therubber -which extends into the channel 32has not *been subjected .to any scraping action whatsoever the liquid asit courses through-the channel 32 will 'not dislodge particles'a-ndaccordingly the-liquid in the bottle-willbe-free of such rubbermatcrial.While the upper cylinder portion of the-needle 21 does, as indicated at34 in Figure 5, enter'the'ru'bber stopper, as discussed 'moreparticularly hereinafter, and accordingly -niight be expected to engagein some dislodgmentof particles, such has not been found to be the fact.

It will be noted in this connection that'the'tot-al length of thecutting edges27, 29, which tapcr-inwar'dly and downwardly from thehollow circular portion of 'the shank to 'a common piercing-point asindicated in Pigure '2 is about of the thickness 'of'th'e stopper andthe total length of-"the upper and lower shank portions issubstantially-the thickness "of the stopper, theexteut to which thecompletely cylindrical portion 2'6 enters the stopper beingsubstantially equal in length to the distancewhich the needleshan'kahpenetrates belowthe stopper into 'the -bot'tle. 'Under this conditionrepeated experiments-have established that substantially no rubberparticles are dislodged.

-In *this connection it -should'=be noted that thethick- *ness *of therubber *stopperand the needle length are related and that the resilienceand abrasion resistance of the rubber of the stopper are factors.

When using stoppers of commerce having normal. resilience, that is,those which will readily engage a bottle in air-tight relation, theoptimum depth of penetration of the needle is approximately one-halt"the thickness of the stopper. With very thick stoppers the depth ofpenetration may, without deleterious effect, be increased if the cuttingangle of the needle is maintained between about 4 to about 12. Smallerangles than about 4 weaken a steel needle to such an extent that cleanpassage through the rubber is difficult while materially large angles donot provide the required cutting length and dislodgment of rubberparticles results.

When using stoppers of very soft rubber, which abrade more easily, it isdesirable that the needle penetrate somewhat less than half the stopperthickness and the resistance of soft rubber is balanced by the higherresilience thereof.

Summarizing these factors it has been found that the depth ofpenetration of the needle should be such that at least .2 of thethickness of the stopper is penetrated by the completely cylindricalneedle portion, a lower limit which prevails for soft rubber. Forthicker stoppers not more than .8 of the thickness of the stopper shouldbe penetrated by the completely cylindrical portion, a limit whichprevails for normally resilient rubbers.

Accordingly it is clear that the length of the shank portion having thecutting edges must be of lesser length than a stopper with which it isassociated, and preferably is not longer than 80% of the stopperthickness; the minimum cutting edge length which a needle may have wouldbe determined by the requirement that the angle formed between thecutting edge portion and the full length wall portion of the needle bebetween about 4 to l2"; where the stopper thickness and material aresuch as to permit it a smaller angle than 4 may be used, but extremecare must then be taken to avoid bending of the needle as abrasion ofthe rubber well would result therefrom.

Also the preferable form of the upper closed shank portion is a circlewhile the lower shank portion is in cross-section preferably a series ofsuperposed minor circular arcs progressively decreasing in peripherallength and terminating in a needle point.

In many instances the rubber stoppers used in the art are not made ofone component but have a central vertically extending portion of softrubber surrounded by a peripheral portion of harder material. In such acase the above limitations apply to the central portion of rubber whichis better adapted to pass the needle.

With the needle structure noted the needle diameter is not a criticalfactor but it is to be noted that for most commercial purposes theuseful diameters lie between about 5 to ,4; inch.

In order to completely illustrate the invention there is shown in Figure4 a structure for the filling of the bottles and it will be noted thatthere is indicated generally at 300 a source of liquid material whichflows through a rubber line 301, which flow may be shut off by stopcock302. In the use of the stainless steel needle in connection with thissource of supply the upper portion 25 is secured into the lower portionof line 301 while the stopcock 302 is closed. The steel needle is thenpassed through the rubber stopper 200 as indicated in Figure 5, thestopcock 302 opened and the liquid from source 300 flows into bottle201. Upon completion of the operation of filling stopcock 302 is closedand the needle 21 is withdrawn from the stopper 200 4 in thebottle 201and the stopper 200 substantially reseals itself. In given instances aswhere a needle has been used which is not quite sharp the stopper 200may have additional sealing material provided therefor.

It will be understood that this invention is susceptible to modificationin order to adopt it to dilferent usages and conditions and accordingly,it is desired to .compre-' hend such modifications within this inventionas may fall within the scope of the appended claims.

We claim:

1. In combination, a resilient stopper for a container and a hollowneedle disposed in the stopper for introducing liquid into the containerthrough the stopper, said needle having an upper shank portion thecrosssection of which is circular throughout and a lower shank portionintegral therewith the progressive crosssections of which are superposedminor circular arcs of progressively decreasing peripheral lengthsterminating in a needle point, the upper and lower shank portions havinga common wall portion and the extremities of the arcs forming cuttingedges which lie in the same plane throughout their entire length andform an angle of 4 to 12 with said wall portion, the relative lengths ofthe upper and lower shank portions of the needle being such that thejuncture therebetween is enclosed by the stopper at about the center ofthe thickness thereof and the distance to which the uper shank portionextends into the stopper is substantially equal to the distance to whichthe lower shank portion extends below the stopper into the container. I

2. In combination, a resilient stopper for a container and a hollowneedle disposed in the stopper for introducing liquid into the containerthrough the stopper, said needle having upper and lower shank portions,the upper shank portion having a circular cross-section throughout andthe lower shank portion having a cross-section which is an open curveprogressively decreasing in peripheral length to a sharp point from thejuncture of the upper and lower shanks, the upper and lower shankshaving a common wall portion and the open curve being defined by opposedcutting edges which lie in the same plane throughout their entire lengthand form an angle of 4 to 12 with said wall portion, the relativelengths of the upper and lower shank portions of the needle being suchthat the juncture therebetween is enclosed by the stopper at about thecenter of the thickness thereof and the distance to which the uppershank portion extends into the stopper is substantially equal to thedistance to which the lower shank portion extends below the stopper intothe container.

References Cited in the file of this patent UNITED STATES PATENTS2,168,270 Paisley et al. Aug. 1, 1939 2,205,964 Taylor June 25, 19402,409,979 Huber Oct. 22, 1946 2,560,162 Ferguson July 10, 1951 2,601,580Yanus June 24, 1952

